§483.45(e) Psychotropic Drugs. §483.45(c)(3) A psychotropic drug is any drug that affects brain activities associated with mental processes and behavior. These drugs include, but are not limited to, drugs in the following categories: (i) Anti-psychotic; (ii) Anti-depressant; (iii) Anti-anxiety; and (iv) Hypnotic
Based on a comprehensive assessment of a resident, the facility must ensure that---
§483.45(e)(1) Residents who have not used psychotropic drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record;
§483.45(e)(2) Residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs;
§483.45(e)(3) Residents do not receive psychotropic drugs pursuant to a PRN order unless that medication is necessary to treat a diagnosed specific condition that is documented in the clinical record; and
§483.45(e)(4) PRN orders for psychotropic drugs are limited to 14 days. Except as provided in §483.45(e)(5), if the attending physician or prescribing practitioner believes that it is appropriate for the PRN order to be extended beyond 14 days, he or she should document their rationale in the resident's medical record and indicate the duration for the PRN order. §483.45(e)(5) PRN orders for anti-psychotic drugs are limited to 14 days and cannot be renewed unless the attending physician or prescribing practitioner evaluates the resident for the appropriateness of that medication.
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Observations:
Based on clinical record review and staff interviews, it was determined that the facility failed to ensure the presence of physician documentation of the clinical rationale for the continued use of multiple psychoactive medications, including antipsychotic and duplicate drug therapy for anxiety disorder, prescribed for one resident out of five sampled residents (Resident 73).
Findings include:
A review of Resident 73's clinical record revealed that he was admitted to the facility on November 9, 2023, with diagnoses that included anxiety, dementia with behavioral disturbance, Lewy body dementia [is a progressive dementia that results from protein deposits in nerve cells of brain and affects movement, thinking skills, mood, memory, and behavior], osteoarthritis [is a progressive dementia that results from protein deposits in nerve cells of brain and affects movement, thinking skills, mood, memory, and behavior], and repeated falls.
A review of the resident's clinical record physician's orders revealed the following orders:
November 9, 2023, Pimavanserin Tartrate Oral Capsule 34 MG [Nuplazid is in the drug class of antipsychotics that is used to treat the symptoms of a certain mental/mood disorder (psychosis) that might occur with Parkinson's disease.] Give 1 capsule by mouth one time a day related to unspecified dementia with behavioral disturbance.
November 11, 2023, Sertraline HCL (antidepressant used to treat depression, panic attacks, obsessive compulsive disorder, post-traumatic stress disorder, social anxiety disorder) Oral Tablet 25 MG Give 1 tablet by mouth one time a day related to unspecified anxiety disorder.
December 12, 2023, Buspirone HCL (anti-anxiety medicine) Oral Tablet 5 MG Give 1 tablet by mouth three times a day related to anxiety disorder.
December 13, 2023, Seroquel Oral (antipsychotic used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder, sudden episodes of mania or depression associated with bipolar disorder) Tablet 25 MG Give 1 tablet by mouth at bedtime related to neurocognitive disorder with Lewy bodies.
December 16, 2023, Ativan (an antianxiety medication used to treat anxiety) Oral Tablet 0.5 MG (Lorazepam) Give 1 tablet by mouth one time a day related to unspecified anxiety disorder and December 30, 2023, Ativan Oral Tablet 0.5 MG (Lorazepam) Give 1 tablet by mouth every 8 hours as needed (PRN) for increased anxiety/agitation related to unspecified anxiety disorder.
A review of the facility's consultant pharmacist's consultation report dated January 3, 2024, identified that Resident 73 had experienced multiple falls that occurred on 11/22/2023, 11/23/2023, and 12/20/2023. A comprehensive review of the medical record was conducted and identified that the following medications may contribute to falls: Two (2) antipsychotics: Nuplazid 34 mg daily and Seroquel 25 mg twice per day for Lewy Body dementia. Ativan 0.5 mg once daily and every eight (8) PRN for anxiety (PRN dose not administered prior to any fall). Sertraline 25 mg daily for anxiety, and Buspar 5 mg three times per day for anxiety.
The pharmacist requested that the attending physician evaluate these medications as possibly causing or contributing to falls, deducing/discontinuing as appropriate and that if the therapy was to continue it would be recommended that the prescriber document an assessment of risk versus benefits, indicating that the medication is not believed to be contributing to falls in Resident 73; b) the facility interdisciplinary team ensures ongoing effectiveness and potential adverse consequences.
A review of the attending physician's progress notes dated January 6, 2024, noted that Resident 73 was receiving Sertraline (Zoloft) and buspirone (Buspar) and Seroquel for the resident's mood.
There was no documented evidence that attending physician documented the individualized clinical rationale for continuing the other psychoactive drugs, including duplicate drug therapy prescribed for anxiety disorder.
A review of the physician's response dated January 16, 2024, revealed that a physician extender, a certified registered nurse practitioner, and the resident's attending physician) addressed the pharmacist's recommendations and decreased the resident's dose of the antipsychotic drug Seroquel dose to 25 mg at bedtime and increased the resident's antidepressant Zoloft to 50 mg oral daily.
Through survey ending February 2, 2024, there was no documented evidence provided that the resident's attending physician documented the individualized clinical rationale for continuing the other psychoactive drugs, including duplicate drug therapy prescribed for anxiety disorder and that the physcian had thoroughly evaluated the combination of these medications and their potential side effects that may be negatively affecting the resident.
Interview with the Director of Nursing (DON) on February 2, 2024, at 10:24 AM, confirmed that Resident 73's attending physician failed to document an evaluation of potential adverse consequences, including an assessment of the resident's condition and documented the clinical necessity of each psychoactive drug, including antipsychotics and duplicate drug therapy for anxiety disorder, in maintaining or improving the resident's function and abilities.
28 Pa. Code 211.9 (k) Pharmacy services.
28 Pa. Code 211.2 (d)(3) Medical Director.
28 Pa. Code 211.5(f) Medical records.
| | Plan of Correction - To be completed: 03/07/2024
Preparation and submission of this POC is required by state and federal law. This POC does not constitute an admission for purposes of general liability, professional malpractice or any other court proceeding.
Step 1
Resident 73's physician provided a progress note addressing the following: rationale and risk vs benefit of each psychotropic medication, justification for continued antipsychotic med use and duplicate drug therapy.
Step 2
To identify other residents that have potential to be affected, the DON/designee will complete an audit for current residents who are on mutltiple psychoactive medications, including antipsychotic and duplicate drug therapy for anxiety disorder to verify presence of physician documentation of clinical rationale for continued use.
Step 3
To prevent this from reoccurring, the DON/designee will notify each physician on unnessary psychotroic use and documentation to support clinical rationale for conintued use of multiple psychoactive medications.
Step 4
To monitor and maintain compliance, the DON/designee will audit monthly pharmacy recommendations to verify that the physician addressed recommendations related to multiple psychoactive medications (including duplicate therapy) and documented the clinical rationale for continued used. The audits will be completed monthly times 3 months. The results of the audits will be forwarded to QAPI committee for further review and recommendations
Step 5
Alleged date of compliance 03/07/2024
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